One of the basic components of the federal government's incentive program for adopting health information technology is a funny little term: "meaningful use." To receive the incentives, physicians have to adopt a system that ensures they can apply meaningful use criteria to their use of an electronic health record, or EHR, system. That's the reason behind the federal government's involvement in the business of certifying EHRs.
According to Farzad Mostashari, M.D., deputy national coordinator for programs and policy in the HHS Office of the National Coordinator for Health Information Technology(www.healthit.gov), or ONC, physicians should view EHR product certification as a sort of "consumer protection" program. Certification can help assure EHR purchasers -- mainly physicians and hospitals -- "that the systems they purchase are capable of helping them achieve meaningful use," he said.
Product certification by one of the six currently ONC-authorized testing and certification bodies(healthit.hhs.gov), or ATCBs, is "not a seal of approval," said Mostashari. And it does not mean that one EHR system is easier to use or better than another. "All it says is that there is a minimal assurance that if you are a motivated provider using this product, you will be able to achieve meaningful use. (The system) will have decision support; it will have registry functions; it will have quality measurement; it will have minimal assurances of interoperability and security."
Mostashari speaks from personal experience. He said that when he was shopping for his own EHR four years ago, "some of the largest EHR vendors in the country said to me 'We can't do quality measurement; we can't do a registry function; we don't believe in decision support.'"
However, passage of the Health Information Technology for Economic and Clinical Health, or HITECH, Act, which is part of the American Recovery and Reinvestment Act of 2009, was a crucial first step toward mandatory product certification, according to Mostashari.
Fast forward to July 28, 2010, when CMS issued a final rule that defined meaningful use criteria for EHRs with the understanding that physicians must demonstrate meaningful use of a certified EHR to qualify for incentive payments of as much as $44,000 through Medicare or nearly $64,000 through Medicaid.
At that point, said Mostashari, certification became necessary to ensure "that the systems (physicians) purchase are capable of helping them achieve meaningful use."
The AAFP Center for Health IT has created a tool called "EHR Technology" Certification(www.centerforhit.org) (Members Only) that is designed to help family physicians readily access a list of electronic health record, or EHR, products that have been certified by a testing certification body, or ATCB, authorized by HHS' Office of the National Coordinator for Health Information Technology, or ONC.
ONC-ATCB certified products are listed by product name, product version and product vendor. The center frequently updates the list as new products become available. Vendor products that are complete EHR systems are indicated under "Type" with a black symbol. Product modules are indicated by symbols that are half-black and half-white. Products created for hospitals are designated with an "H."
To date, "more than 400 products and modules are certified," under a temporary certification program, and the number is growing daily, said Mostashari. The ONC aggregates results from all of the various ATCBs into its certified health IT product list(onc-chpl.force.com).
HHS anticipates that the temporary certification program will be replaced in 2012 with the ONC's permanent certification program.
Kyle Meadors is the director of EHR testing for the Drummond Group Inc., one of the first two certified testing bodies approved by the ONC in August 2010. He stressed that ATCBs go through a rigorous application process to show they are in compliance with the National Institute of Standards and Technology.
Part of Meadors' job is to serve as a test proctor to ensure that a vendor's EHR product is compliant with the necessary criteria to ensure that the end user can achieve meaningful use.
For example, if a particular meaningful use measure requires that a certain number of unique patients must have an active problem list, "we need to make sure that the EHR we're testing has the capability of electronically recording a problem list," said Meadors.
A vendor is free to choose which ATCB it wants to test its product; certification fees are paid directly to the certifying body by the vendor.
The Drummond Group most often relies on "remote" testing, which means video access allows Meadors to view the system being tested. "As proctor on the day of testing, I will lead (the software vendor team and product) through the test, witnessing and verifying that they have the necessary capability and functionality to meet the criteria in question," he said.
Remote testing reduces travel costs and, ultimately, reduces the cost of testing. That's a plus for the end buyer because the cost of certification testing is considered in the final pricing.
Each certified product -- be it an entire EHR system or just one module of a system -- is issued a certification identification number that physicians then use to attest that they have used a certified product to meet the meaningful use measures.
Physicians should double-check certification numbers when verifying their EHR's certification against the ONC's certified product list, Meadors cautioned. He noted that it is not unusual for a vendor to have multiple product lines, and a product certification number applies only to a specific version of an EHR product. For example, certification for a vendor's EHR version 2.0 does not apply to the vendor's EHR version 1.0.
"Software versions can change functionality," said Meadors.
Drummond Group CEO Rik Drummond said his company has nearly 170 product certifications under its belt and is proud of the work it's doing.
Medicine today is not like it was 150 years ago, when patients had one doctor who did everything for them, said Drummond. Now patients have a primary care physician and often a cadre of other medical professionals that provide additional health care services.
"Information-sharing between doctors becomes paramount in avoiding errors and in making sure that the patient gets the best service possible throughout his or her lifetime," he said.
The Certification Commission for Health Information Technology, or CCHIT, owns the distinction of launching the first certification program for ambulatory EHRs in May 2006.
"Until September 2010, we were the only EHR certification body," said CCHIT Marketing Director Sue Reber, noting that in February 2009, the passage of the HITECH Act paved the way for competing certification bodies.
She noted that CCHIT still maintains its own separate certification program that, among other things, tests a product's integration of all its functionality, interoperability and security capabilities. ONC-ATCB certification does not require that extra level of testing, said Reber.
"Providers are on their own when it comes to determining if product modules testing in the ONC-ATCB program work together without further investment in interface development," she said.
"Our mission has always been to accelerate the adoption of EHRs. Helping physicians feel more comfortable about making that investment is part of encouraging that kind of adoption, and that's what certification was intended to do."
According to Reber, 56 products are available to physicians that have what she called "dual certification" -- that is a certification number earned through the ONC-ATCB certification program, as well as via CCHIT's original and exclusive certification program.
Reber noted that EHRs existed long before product certification came into vogue. "EHR technology is not new," she said, but product certification is beginning to have a positive effect on the rate of EHR adoption. "In the past, physicians were very unsure about the value of this technology, and they had trouble discerning what (EHR system) they needed in their practices."
Certification will help physicians make the right choices, she added.